As we reported last month, the FDA's decision to forgo legal reviews prior to sending warning letters carries the risk of discontinuity between districts in their interpretation of regulations. That continuity break could lead to regulatory districts overstepping their authority, Jim Prutow of PRTM recently told us.
In fact, it's already happened, says Prutow, partner in the consultancy's healthcare practice. He cites the following "questionable warning letter observations" from earlier this year.
The first comes from the FDA's warning issued in July to Abbott Diabetes Care. The questionable observation involves Abbott's failure to have sufficient personnel with the necessary education and background. The agency uses the company's own job description as the standard: "The job description for the director of quality systems requires that the person have a Bachelor of Science/Technical/or Engineering discipline. The person holding the position does not have this type of degree, but rather a Business Administration degree." The letter also notes that the regulatory affairs manager, quality control supervisor and calibration coordinator are each equally deficient in degrees or experience as required by their position descriptions.
"Personnel might have extensive experience in the field," says Prutow, "which might be the reason for overlooking their lack of a degree."
Stericon too came up short in FDA's view of worker qualifications, as detailed in a warning letter (WL: 320-10-008) from August. But this time, the emphasis is on training rather than education. Stericon failed to ensure that manufacturing workers had the "education, training, and experience, or any combination thereof," to enable them to perform their assigned tasks, says the letter. "Your firm should establish a training program that includes an initial assessment, routine evaluation, timeframes for re-qualification, and more frequent qualification activities, when warranted."
The observation is questionable, Prutow says, because it's safe to assume that an operator who's been trained on a manufacturing SOP has completed the minimum requirements of training. Sufficient education and experience, combined with the SOP training, yield a qualified operator.
In this example, the FDA has "cited the company for not having a qualifying training program, which per the regulation (211.25) is open to interpretation," he adds.
Then there's the Optovue warning letter from June. In this case, the company was cited for a lack of procedures for evaluating complaints to determine whether they should be filed as Medical Device Reports, as regulations require. "Your complaint procedure lacks the ability to capture patient involvement; therefore, you are unable to evaluate whether the complaint represents an event requiring the submission of a Medical Device Report," says the letter.
Prutow says the regulations contain no requirement for capturing patient involvement, as long as the company SOP states when a complaint is reportable. "Patient involvement" is open to interpretation in the regulation.